Gwendolyn Byrd

Gwendolyn Byrd

Work History

Work History
Aug 2010 - Feb 2011

Clinical Coordinator, Division of Cancer Research and Training

CHARLES R. DREW UNIVERSITY OF MEDICINE AND SCIENCE
  • Liaised between senior research staff of the Drew/UCLA/Cedars Cancer  research partnership
  • Liaised between Clinical Trials Unit Resource, Cancer Outreach Program and Partner Institutions
  • Maintained regulatory documents, binders and IRB submissions
  • Prepared for IRB site monitoring visit
  • Assisted in protocol preparation, development of oncologists and data training surveys
  • Conducted UCLA-Olive View Clinical Trials Site Visit
  • Trained student interns on data abstraction, standard operating procedures and clinical trial procedures
  • Prepared hospital census report
  • Prepared Clinical Trials Information page for Division Web site
  • Attended and coordinated outreach meetings and conferences
Aug 2009 - Aug 2010

Regulatory/Research Coordinator, Division of NanoMedicine

UCLA SCHOOL OF MEDICINE
  • Prepared Asthma Center for initiation by National Institute of Allergy and Infectious Diseases (NIAID)
  • Served as liaison between sponsor and in-house study team
  • Worked with PI to assure compliance with GCP, FDA Regulations and protocol
  • Maintained regulatory documents, binders and IRB and Investigational New Drug (IND) submissions
  • Ensured progress of studies from approval, through completion and post-study activities
  • Conducted screening, informed consent process, enrollment, withdrawal and completion
  • Responsible for data management from CRF completion, data entry into Electronic Data Capture (EDC) systems and query resolution
  • Maintained drug accountability
Apr 2009 - Aug 2010

Research Coordinator, Weintraub Center for Reconstructive Biotechnology

UCLA SCHOOL OF DENTISTRY
  • Responsible for the day to day conduct of clinical trial from start-up to closeout
  • Ensured compliance with protocol guidelines and requirements of regulatory agencies
  • Maintained regulatory documents, binders and IRB submissions
  • Assisted in the preparation of  protocol amendments or modifications to study design
  • Responsible for data entry onto CRFs
  • Coordinated focus groups, collected, scored and transcribed data
  • Prepared for marketing of Research Core providing facilities, regulatory and IRB support
Feb 2009 - Aug 2009

Study Coordinator

LOS ANGELES INFERTILITY & PROSTATITIS MEDICAL GROUP
  • Responsible for the day to day conduct of clinical trial from start-up to closeout
  • Served as liaison between clinical trial sponsors and in-house study team
  • Worked with PI to assure compliance with GCP, FDA Regulations & protocol
  • Prepared for site qualification, initiation, monitoring and close-out visits
  • Used Impala and OC RDC Systems for enrollment, subject tracking and data entry
  • Maintained regulatory documents, binders and submissions to Quorum IRB
  • Performed electrocardiograms, bladder ultrasound, vital signs and processed lab samples
May 2008 - Nov 2008

Regulatory/IRB Services Administrator, Office of Clinical Trials, David Geffen School of Medicine

UCLA MEDICAL CENTER
  • Facilitated pre-study regulatory submissions process (UCLA IRB and supplemental committee applications)
  • Managed the Western Institutional Review Board (WIRB) pilot program
  • Trained department level administrators to participate in the pilot program
  • Performed Quality Assessment review of informed consent documents
  • Participated in Quality Assessment Site review of Western Institutional Review Board
  • Performed detailed protocol review
1996 - 2008

Research Coordinator, UCLA Medical Center

UCLA MEDICAL CENTER
  • Department of Urology, Aging and Memory Research Center, and Neuropsychiatric Institute
  • Managed clinical trials and observational cohort of urological diseases, memory and aging, Alzheimer's disease and HIV/AIDS
  • Responsible for IRB submission 
  • Prepared grant progress reports and continuation budgets to funding agencies
  • Managed and supervised the submission of center grant to National Institutes of Health
  • Responsible for the day to day conduct of clinical trial from start-up to closeout
  • Developed Standard Operating Procedures, CRFs and subject tracking system
  • Responsible for entering study data onto CRFs, data entry using EDC systems
  • Conducted neuropsychological and subject interviews and family history questionnaires
  • Managed petty cash fund and multiple research funds
  • Assisted in managing payroll and personnel procedures

Education

Education